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SÃO PAULO – The Butantan Institute yesterday signed a cooperation agreement with the MSD Pharmaceutical Lab to share the scientific results obtained so far in the search for a new dengue vaccine . The US company will pay up to $ 101 million to Butantã for technology transfer and study information, or $ 26 million immediately and the rest for goals.
The immune system developed by Butantã is considered to be one of the most promising since it has shown efficacy ranging from 85% to 90% during the previous research phases and because it is already at a stage advanced tests on humans. MSD is also studying a dengue vaccine that meets the same specifications, but is still in the initial phase.
Through the partnership, the institute will also receive royalties on the sale of the product by MSD in the international market, since Butantã will have commercial rights in Brazil and MSD abroad. For Dimas Tadeu Covas, director of the institute, in addition to the additional resources that the entity will receive from MSD, the partnership is positive because it shows the world the quality of Brazilian research. "Brazil is generally a technology importer and through this partnership we will be exporting technology and knowledge," he said.
According to Guilherme Leser, director of access and government relations at MSD, the pharmaceutical company can still collaborate in product approval in other countries, thanks to its international experience. Butantã expects the vaccine to hit the market in 2020, three years after the one promised in 2015.
Already on the international market, the product should be available later: in the best case, in 2022, according to the estimate of the director of the MSD. Indeed, even with access to Butantã's research results, the pharmacist should include volunteers from other countries in the clinical study to adhere to the rules of the regulatory bodies of countries like the United States. -United. In addition, certain product characteristics, such as dose volume and cooling conditions, should be adapted to the international market.
In order to reach the status of the research, the Butantan received investments of R $ 224 million, including contributions from the National Development Bank (BNDES), the Foundation for Support to State of São Paulo Research (FAPESP), Butantã Foundation and Ministry of Health.
First vaccine. When it arrives on the market in 2020, the Butantã vaccine will be the first competitor of the Sanofi Pasteur immune vaccine, the first product of its kind to be launched in the world. Registered in Brazil in 2015, the immunizer is already on the market, suspecting that it has shown only 40% protection in clinical trials.
Last year, another setback: the pharmacist discovered in post-marketing studies that the vaccine increased the risk of dengue complications in people who had never been infected with the virus. The immunizer is therefore only indicated for patients who have had some form of dengue and who want to protect against other serotypes – there are four in all.
To end the last phase of clinical research and request registration of the product with the National Health Surveillance Agency (Anvisa), Butantã must attract another 2,000 volunteers for the test. In total, the study will involve 17,000 participants in groups of adults, adolescents and children. About 15,000 volunteers have already been included and the adult and adolescent groups are already finished. Now the volunteers are missing children. Based on the results of previous phases of research on Butantã, the prediction is that it is indicated for people from 2 to 59 years old.
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